Cleared Traditional

K964455 - POLYFIN WITH WINGS INFUSION SETS

K964455 is the FDA 510(k) clearance for POLYFIN WITH WINGS INFUSION SETS by Medtronic Minimed. It is a Class 2 General Hospital device (product code FPA) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K964455 · Medtronic Minimed · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1997
Decision
85d
Days
Class 2
Risk

K964455 is an FDA 510(k) clearance for the POLYFIN WITH WINGS INFUSION SETS, MODELS 306, 307, 333. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Medtronic Minimed (Sylmar, US). The FDA issued a Cleared decision on January 30, 1997 after a review of 85 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medtronic Minimed devices

Submission Details

510(k) Number K964455 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 1996
Decision Date January 30, 1997
Days to Decision 85 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 129d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FPA Set, Administration, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FPA Set, Administration, Intravascular

All 445
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K964455.
CONMED: STAT 2 AND STAT 2 PUMPETTE EXTENSION SETS AND MASTERFLOW AND MASTERFLOW PUMPETTE PRIMARY SETS
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K963981 · Vygon Corp. · Feb 1997
POLYFIN QR WITH WINGS INFUSION SETS, MODELS 365, 366, AND 367
K964456 · Medtronic Minimed · Jan 1997
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K962893 · Baxter Healthcare Corp · Oct 1996
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K961794 · Merit Medical Systems, Inc. · Aug 1996